Tender For Seed Bioreactor Total Volume: 7 Liter; Clean-in place (CIP) and sterilize-in-place (SIP) function Automatic Temperature control Automatic Filter Sterilization Automatic Vessel Cleaning and Sterilization Automatic Foaming Control Automatic Agitation Control Automatic Aeration Control Automatic DO Control with Cascading function Automatic Nutrient Feeding Automatic Back Pressure Monitoring and control Independent control panel for seed reactor with Touchscreen HMI High Speed PLC TCP Modbus communication protocol Relays Digital and Analog cards Pneumatic manifolds For the Seed bioreactor vessel Design Pressure Full vacuum- 3.0 Kg/cm2 Hydraulic Test Pressure 4.0 Kg/cm2 Working Temperature 10 to 140 deg. C Design Temperature 0 to 150 deg. C For the seed bioreactor jacket Design Pressure Full vacuum- 3.0 Kg/cm2 Hydraulic Test Pressure 4.0 Kg/cm2 Working Temperature 10 to 140 deg. C Design Temperature 0 to 150 deg. C Material of Construction All Wetted Parts SS-316L Jacket (Limpet)/Non-Wet Parts SS -304 Cladding/Leg Support SS-304 Gaskets/ O-rings Silicon & EPDM (Regulatory Compliant) Inner Surface 220 grit Finished & Mirror polished Ra<0.4μm External Finish 180 grit Mat finish Agitation Drive Top Driven Single Mechanical Dry seal Impellers 6 Blade Ruston Turbine - 3 No’s Baffles 4 Nos., Fixed Type RPM 50 -1000 Sparger: Ring sparger Motor type Servo Motor Standard Impeller: Segmented Blade Impellers for mammalian cell cultivation 4 Nos. RPM: 20-200 for cell culture experiments Sparger: Micro-sparger Ports In Top Dish for Feeding Septum ports (Acid, Base, Nutrient & Antifoam) Inoculation-Septum ports, Spare Ports Instruments -Pressure gauge, Foam Sensor, Pressure Transmitter Air exhaust, Safety Valve In Side Wall for pH Sensor DO Sensor OD Sensor ORP Sensor Sampling valve Temperature sensor (RTD) Light Glass Sight Glass Jacket Inlet and Outlet Air Sparger inlet, Air Overlay Port In Bottom for 1/2” Bottom Flush Valve Aeration Designed for 0.1 to 2 VVM Sparger: Ring type sparger with bottom perforations Air filters: Inlet 1-micron pre filter and 0.2-micron filter/ Exhaust-0.2-micron filter Filters Integrity Testing Provision for In-situ integrity testing Filter Sterilization Automatic Air & O2 Volume Measurement & Control Automatic through MFC and PID control Air Exhaust Reflux condenser that can efficiently handle a volume of out flowing air Back pressure control Control through Automatic Control Valve Sampling System Type Zero Dead Leg Sampling valve with complete assembly consists of Steam in, Steam lock and Sampling valve. Whole assembly In-situ Sterilizable Harvesting System Type Zero Dead Leg Harvesting valve with steam in valve, Transfer Valve and Drain valve. Whole assembly is In-situ Sterilizable SIP System Type Auto SIP system Validation As per ASME BPE Requirements 121 Deg. C in all the wet process area Thermal Circuit: Temperature control with heating assembly and circulation pump, temperature sensor, and all required valves to be connected to water supply. Vessel Support with Leg Support Skid Mounted Complete Independent System in modular SS skids Utility Pipeline: All utility pipelines and process Pipelines need to be connected and integrated into separate skids. Temperature control: Type: PID/PLC Fully Automatic Range : 0-60 deg. C Measurement precision: ± 0.1°C Control precision: ± 0.2°C (up to 40° C) Temp. sensor: Pt.-100- one no, Heating Assembly For temperature control during process Sterilization Control Type PID/PLC Range : 0-150 deg. C Timer : 0-60 Min Type: Automatic Automatic Aeration Control Type Automatic with PID/PLC control Mass flow controllers: 5 Nos. Oxygen, Nitrogen, Air., CO2 and extra MFC Range (Air | O2) 0 – 50 LPM Output 4-20 mA Control Automatic Control RPM Control RPM 20 – 1000 RPM for both microbial and mammalian cell culture AC drive: Electronic Variable Frequency Drive Control, Fully Automatic pH Monitoring & Control pH Sensor: Gel filled autoclavable probe Housing: SS-316L Housing Type PID based automatic control Range 2 – 14 pH Peristaltic Pump 2 nos., Automatic DO Control Sensor Optical DO Type CASCADE with RPM, Air , O2 Flow, Pressure and Feeding Housing SS-316 Range 0-100% Nutrient Feeding Type Automatic PID/PLC based DO2 control Peristaltic Pump 2 nos., Pump Control Auto Foaming Control Sensor Conductivity sensor Type Automatic Peristaltic Pump 1 Nos Batch Weight Monitoring Sensor Load Cell Type Shear Beam Load Cell Transmitter Digital display with indicator with 4-20 mA isolated output for PLC Control Panel Type Panel fitted on Skid HMI 9” Touchscreen interface PLC High Speed PLC I/O Cards Digital & Analog cards Output Transistor Output with relays Communication Protocol TCP IP MODBUS communication protocol Control for Automatic valves Through Pneumatic Solenoid valves with manifolds for space saving. Bioreactor Total Volume: 50 liter Working volume: 35 liters with agitation, aeration, sterilization and temperature control Clean-in place (CIP) and sterilize-in-place (SIP) function and independent operation with respect to seed reactor Automatic Temperature control Automatic Filter Sterilization Automatic Vessel Cleaning and Sterilization Automatic Foaming Control Automatic Agitation Control Automatic Aeration Control Automatic DO Control with Cascading function Automatic pH Control Automatic Nutrient Feeding Automatic Back Pressure Monitoring and control Independent control panel for bioreactor with Color Touchscreen HMI Advance High Speed PLC TCP MODBUS communication protocol Relays Digital and Analog cards Pneumatic manifolds For the Bioreactor vessel Design Pressure : Full vacuum- 3.0 Kg/cm2 Hydraulic Test Pressure: 4.0 Kg/cm2 Working Temperature : 10 to 140 deg. C Design Temperature : 0 to 150 deg. C For the Bioreactor jacket Design Pressure : Full vacuum- 4.0 Kg/cm2 Hydraulic Test Pressure: 6.0 Kg/cm2 Working Temperature : 10 to 140 deg. C Design Temperature : 0 to 150 deg. C Material of Construction All Product Contact Points: SS-316L All welded parts: SS-316L Jacket (Limpet)/Non-Wet Parts SS -304 Cladding/Leg Support SS-304 Gaskets/ O-rings Silicon & EPDM (Regulatory Compliant) Finishing Inner Surface 220 grit Finished & Mirror polished Ra<0.4μm External Finish 180 grit Mat finish Agitation for microbial culture Drive : Top Driven Single Mechanical Wet seal Impellers : 6 Blade Ruston Turbine - 3 No’s Baffles : 4 Nos., Fixed Type RPM : 50 -1000 Motor type : Standard AC motor/Servo motor Sparger : Ring Sparger Agitation for mammalian culture Drive : Top Driven Single Mechanical Wet seal Impellers : Segmented Blade Impellers Baffles : 4 Nos., Fixed Type RPM : 20 -200 Motor type : Standard AC motor/Servo motor Sparger : Micro Sparger Ports In Top Dish for Feeding Septum ports (Acid, Base, Nutrient & Antifoam) Inoculation-Septum ports, Spare Ports Instruments -Pressure gauge, Foam Sensor, Pressure Transmitter Air exhaust, Safety Valve 44 In Side Wall for pH Sensor DO Sensor OD Sensor ORP Sensor Sampling valve Temperature sensor (RTD) Light Glass Sight Glass Jacket Inlet and Outlet In Bottom for Air sparger inlet, Air Overlay Port 1/2” Bottom Flush Valve Aeration Designed for 0.1 to 2 VVM Sparger: Ring type sparger with bottom perforations and Microsparger Air filters: Inlet 1-micron pre filter and 0.2-micron filter/ Exhaust- 0.2-micron filter Filters Integrity Testing : Provision for In-situ integrity testing Filter Sterilization Automatic Air & O2 Volume Measurement & Control : Automatic through MFC Air Exhaust : Reflux condenser that can efficiently handle a volume of out flowing air Back pressure control : Control through Automatic Control Valve Sampling System Type: Zero Dead Leg Sampling valve with complete assembly consists of Steam in, Steam lock and Sampling valve. Whole assembly In-situ Sterilizable Harvesting System Type Zero Dead Leg Harvesting valve with steam in valve, Transfer Valve and Drain valve. Whole assembly is in-situ Sterilizable SIP System Type : Auto SIP system Requirements : 121 Deg. C in all the wet process area Validation : As per ASME BPE Thermal Circuit: Temperature control: With heating assembly and circulation pump, temperature sensor, and all required valves to be connected to water supply. Vessel Support with Leg Support Skid Mounted : Complete Independent System in modular SS skids Utility Pipeline: All utility pipelines and process Pipelines need to be connected and integrated into separate skids. 45 Control Panel Type : Panel fitted on Skid HMI : 9” Touchscreen interface PLC : High Speed PLC I/O Cards: Digital & Analog cards Output :Transistor Output with relays Communication Protocol : TCP IP MODBUS communication protocol Control for Automatic valves : Through Pneumatic Solenoid valves with manifolds for space saving Temperature control: Type: : PID Fully Automatic Range : : 0-60 deg. C Measurement precision : ± 0.1°C Control precision: : ± 0.2°C (up to 40° C) Temp. sensor: :Pt.-100- one no, Heating Assembly : For temperature control during process Sterilization Control Type : PID Range : 0-150 deg. C Timer : 0-60 Min (Custom change possibilities) Type : Automatic Automatic Aeration Control Type : Automatic with PID control Flow Meter : MFC based Range (Air | O2) : 0 – 50 LPM Output : 4-20 mA Control : Automatic Control 5 Nos. MFC for Oxygen, Nitrogen, Air., CO2 and extra spare MFC RPM Control RPM : 20-1000 PPM AC drive: Electronic Variable Frequency Drive Control, Fully Automatic pH Monitoring & Control pH Sensor : Gel filled autoclavable probe Housing: : SS-316L Housing Type : PID based fully automatic Range : 2 – 14 pH Timer : Acid or Base Timer fully automatic Peristaltic Pump : 2 nos., Automatic DO Control Sensor: Optical DO Type : CASCADE with RPM, Air , O2 Flow, Pressure and Feeding in automatic manner Housing: SS-316 Range : 0-100% Nutrient Feeding Type : PID control with DO2 Peristaltic Pump : 2 nos., 46 03 Pump Control :Auto Foaming Control Sensor : Conductivity sensor Type : Automatic Peristaltic Pump : 1 Nos Batch Weight Monitoring Sensor : Load Cell Type : Shear Beam Load Cell Transmitter : Digital display with indicator with 4-20 mA isolated output for PLC Back Pressure Monitoring & Control Sensor : Piezo-resistive sensor Range : 0-4 Kg/cm2 Connection: Sanitary connection TC type Control : Valve Automatic SS Pressure Control Valve Bypass : Provided for manual control with Globe/Diaphragm valve Safety Safety for vessel Safety Valve : Sanitary Safety valve Pressure Rating : 2 Barg Temperature : 0-130 deg. C Seat : EPDM/Silicon MOC : SS-316L Safety for Jacket Safety Valve : Safety valve Pressure Rating : 3.6 Barg Temperature : 0-150 deg. C Seat : EPDM/MTM MOC : SS-316L Software for controlling the seed and bioreactor SCADA Software (21 CFR part 11 complied – GMP Model) for seed and bioreactor control Display of all parameters of all reactors in the same page with pop-up set point window. Display of minute wise updates of all configured parameters Error display and control page Feed pump configuration page – pump calibration; pulse width; feed volume; feedlizer, etc. details. Acid/alkali/antifoam pump page - pump on /off and status configuration Controller configuration page- PID, valve opening, high set points, low set points, etc. configuration History display of the changes effected during the batch progress – pass word protection Report Manager – daily/batch wise datasheet of all parameters on hourly execution minute basis Alarm for all parameters/valves depends on the conditions and set point deviations Data acquisition for all parameters. Remote controlling from a Remote PC. Plotting and display of up to 10 process variables for on-line or off-line values. Data Export of finished or active batches can be further processed by 3rd party software 47 04 (e.g. Excel). The SCADA Software will be given with a Personalized Serial Number (ID) or Hardware Lock installation. Indicators for the SCADA software: Culture medium temperature indication Culture medium pH indication Culture medium dissolved oxygen indication Agitation rate indication Vessel pressure indication Culture medium redox indication Exhaust Gas CO2 & O2 Level Indications Air inflow rate indication Nutrient flow indication for Fed batch reactor Controls using the SCADA software: Culture medium temperature control (Range: 5 – 600C; Precision +/- 0.10C) Culture medium pH control Culture medium DO control Culture medium Redox Control Exhaust Gas Level Control Agitation control Vessel Pressure control Foam level control Air Flow control Nutrient Flow Control Alarms using the SCADA software: High/Low temperature audiovisualsignal High/Low pH audiovisual signal High/Low-agitation rate audiovisual signal High/Low-DO2 audiovisual signal High/Low-Redox audiovisual signal High/Low-Exhaust gas levels audiovisual signal High/Low-vessel pressure audiovisual signal High/Low-Air flow rate audiovisual signal Steam generator for sterilization and temperature control of both seed and bioreactor Capacity: 20 Kg/hr Type: Electric, Non IBR Portability: Yes with Caster Wheels Power: 14 KW All Parts Tank and Pipe Line: SS-304 Working Pressure: 4 Barg Design Pressure: 7 Barg Tank Capacity: As per Design Water Level Control: Automatic Pressure Control: Automatic Heater Cut off: Automatic Power Input: 3 Phase Insulation: Glass Wool Cladding: Insulation Cloth Water Inlet (inches) ½ Steam Outlet (inches) ½ Water Feed Pump 20LPM, 45M 48 05 06 07 Bottom Drain Valve (inch) ½ Inlet/Outlet Valves (Steam Valves) SS-304 Trolley Power Coated MS Panel with MCB & contractors On the Skid Automatic Safety Valve (inch) ¼ Flexible Steam Pipe Required (Meter) 5-10 Electrical Connections 440V, 3Phase, 50 Hz Chiller Circulator MOC: SS-304 (Wet Parts) Capacity: 20L Temperature Range Ambient to 5 deg. C Measurement Precision ±0.20 degree C Control: Digital Temperature PID Control Heat Removal Capacity: 6000 BTU/Hr Portability Yes with Caster Wheels Hermetically sealed compressor with environment friendly CFC free refrigerants Built-in circulator pumps for efficient circulating processes Offers highest level of performance, flexibility and control for most demanding application Low noise level Microprocessor based PID DIGITAL TEMPERATURE INDICATOR CUM CONTROLLER Temperature range: 8 Degree C to Ambient With timer, alarm & over temperature protection Powerful circulation pump to work on 220/230 volts, 50/60 Hz AC Supply. Air Compressor, Tank mounted, with low power consumption, high productivity, compact, low noise and vibration free Capacity 9.4 CFM Working Pressure 8.5 Kg/cm2 Air Receiver 90 L Motor Rating 2 HP Air Receiver, complete with Pressure Gauge, Pressure Switch, Drain Valve, and Safety Valve The Compressor should be completely balanced, fitted on wheels, therefore does not require grouting Specification of Two Stages Filtrations Pre Filter (1st Stage) 5 micron Sub Micro Filter (IInd Stage) : 0.01 micron Piping requirements a. Utility Pipelining Flexible Utility Pipelining b. Transfer Pipelining Sanitary Aseptic Transfer Lines from 7L Fermenter to 50L Fermenter (SS-316, ASTM-A270, Fully Sterilizable with Zero dead leg as per ASME BPE 2009 guidelines 49 08 09 10 11 Workstation for processing and analyzing fermentation data Intel Xeon Processor, Windows 10 Enterprise Edition, Hard Disk: 5TB, RAM: 64GB with one 27 inch HD monitor displays with laser printer. IQOQ and PQ Standard IQOQPQ protocol must be provided and done during the system installation. Instrument qualification and calibration must be done for two subsequent years after the installation Training Onsite installation and training for instrument operation as well as processing software’s for 15 participants. Warranty Three-year comprehensive “spares-included” warranty. Vendors must mention exhaustively “All parts are covered under warranty
